Process Flow
Interactive Working Sessions
Initial 1.5-hour discovery followed by a 2-hour deep dive
Desk Analysis
In-depth research by Complear's regulatory experts
Draft Report & Feedback
Discussion of findings and recommendations
Final Delivery
Comprehensive Regulatory Strategy Report
Key Deliverables
- Regulatory classification scenarios
- Intended purposes proposals
- Regulatory pathways overview (EU MDR and FDA)
- Quality and technical documentation requirements
Map Your Path to Market, Before You Build
Before investing in product development or certification, understanding your regulatory pathway is critical. Complear's Regulatory Strategy offers a tailor-made roadmap for software-based medical products, clarifying requirements, timelines, and market options.
Our Approach Includes:
- Mapping Product Scenarios and Intended Purposes
- Assessing whether your product qualifies as a Medical Device in Europe
- Determining Classification under the MDR
- Outlining General Regulatory Requirements
- Defining Regulatory Pathways for CE Marking and FDA approval
Quality Management Systems
At Complear, we design, implement, and audit QMS frameworks compliant with ISO 13485:2016/A1:2021, EU MDR/IVDR, and the upcoming FDA QMSR with ISO standards.
QMS Documentation Templates + Guidance
Comprehensive templates supported by personalized guidance, documentation reviews, and training.
B1 PackageInternal Audits & Gap Analysis
Ensuring readiness for certification and identifying improvement opportunities before official audits.
B2 PackageTraining & Capacity Building
Empowering your team to maintain and evolve your QMS independently with focused, hands-on training.
B3 PackageNavigate Complex Regulatory Pathways
Bringing a medical device or diagnostic to market requires expert navigation of complex regulatory pathways. At Complear, we guide you through every step — from regulatory strategy and product classification to technical documentation, clinical evaluation, risk management, and final submission.
Whether you are aiming for CE Mark approval under the EU MDR/IVDR or FDA clearance in the United States, our team ensures a smooth, efficient, and compliant journey to market.
EU MDR & IVDR Compliance
CE MarkComplete CE Mark guidance from classification to technical documentation and Notified Body submission.
510(k) & De Novo
FDAFDA clearance pathways with strategic guidance on predicate selection, testing requirements, and submission preparation.
Smart and Compliant SaMD Development
Complear supports companies through the complex journey of SaMD development, ensuring that your software meets both technical excellence and regulatory compliance from the start.
We guide you through key engineering milestones, from software architecture to documentation practices, aligned with IEC 62304, ISO 14971, and other relevant standards.
Software Development Plan
Comprehensive plan aligned with regulatory requirements
Risk Management File
Complete software risk management documentation
V&V Protocols
Verification and validation testing frameworks
Clinical & User Experience
Usability testing and clinical evaluation support
Validate Safety, Effectiveness & User Satisfaction
We guide you through usability testing aligned with IEC 62366-1:2015, ensuring your product meets regulatory requirements while delivering an excellent user experience.
Usability Testing Support
Protocol Design & Review
Our experts help design protocols and review your usability tests to ensure they meet regulatory expectations, including common Notified Body practices and FDA HFE requirements.
Test Execution Support
Working with our network of specialized usability researchers and clinical experts, we support you in designing and executing robust usability tests that validate product safety, effectiveness, and user satisfaction.
Clinical Evaluation
Evidence Compilation
From planning to reporting, our experts ensure your clinical evidence supports your claims, risk assessments, and regulatory submissions according to EU MDR and FDA guidelines.
Post-Market Clinical Follow-up
We also support the design and execution of Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) activities to maintain compliance over time.